Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

During a placebo lead-in period, participants were counselled on dietary and life-style modifications. Anti-diabetic therapy should be kept constant 4 weeks prior to enrolment. Participants eligible for the study were stratified according to age (<65 years or ≥65 years), insulin use and time from most recent qualifying CV event (>1 or ≤1 year).

Reporting Groups

Description

Dapagliflozin

Dapagliflozin 10 mg plus usual care

Placebo

Placebo plus usual care

Participant Flow: Overall Study

Dapagliflozin

Placebo

STARTED

482
[1]

483
[2]

COMPLETED

441

428

NOT COMPLETED

41

55

Adverse Event

4

12

Death

2

1

Withdrawal by Subject

8

16

Lost to Follow-up

0

2

Poor/non-compliance

3

4

Subject no longer meets study criteria

15

13

Incorrect enrollment

6

4

Safety

0

2

Administrative reason by sponsor

0

1

Various

3

0

[1]

Of 482 part. 480 were included in full analysis set. Thereof, 1 part. treated but not randomized.

[2]

Of the 483 participants only 482 were included in the full analysis set.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Full Analysis Set defined as all randomized participants (as randomized) who received at least one dose of double-blind study medication, who have a non-missing baseline value and at least one post-baseline efficacy value for at least one efficacy variable during double-blind treatment period.

Reporting Groups

Description

Dapagliflozin

Dapagliflozin 10 mg plus usual care

Placebo

Placebo plus usual care

Total

Total of all reporting groups

Baseline Measures

Dapagliflozin

Placebo

Total

Number of Participants
[units: participants]

480

482

962

Age
[units: Years]Mean (Standard Deviation)

63.9
(7.60)

63.6
(7.02)

63.8
(7.31)

Gender
[units: Participants]

Female

159

159

318

Male

321

323

644

Race/Ethnicity, Customized
[units: Participants]

White

454

449

903

Black/African American

9

10

19

Asian

6

7

13

Other

11

16

27

HbA1c
[units: Percent]Mean (Standard Deviation)

8.04
(0.759)

8.08
(0.795)

8.06
(0.777)

Body weight
[units: kg]Mean (Standard Deviation)

94.53
(17.804)

93.23
(16.842)

93.88
(17.332)

Systolic Blood Pressure
[units: mmHg]Mean (Standard Deviation)

134.9
(14.53)

134.6
(13.96)

134.7
(14.24)

Number of participants with BMI >= 27 kg/m2 at baseline
[units: Participants]

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
If an Investigator requests permission to publish data from this study any such publication is to be agreed with AstraZeneca (AZ) in advance. The investigator agrees to provide AZ as soon as possible with drafts of proposed publications. Unless otherwise agreed, AZ shall have a period of 60 days from receipt of the proposed final manuscript to review it and may within such time require that submission for publication of the manuscript be delayed in order for AZ to file patent applications.